The owner of Germany’s Adhesys Medical said last week that it won CE Mark approval in the European Union for its Flix topical skin adhesive for surgery.
Grünenthal, which in May 2016 inked a distribution deal with Adhesys, said it acquired Adhesys outright in April 2017. An internal surgical sealant based on the same polyurethane-based technology is in the works, the company said.
“The CE-Certification is a remarkable milestone in executing our strategy. With devices and technologies like surgical sealants we broaden our portfolio beyond the development of new chemical entities (NCEs) in focus areas of high unmet medical need, that is pain and inflammation,” Grünenthal CEO Gabriel Baertschi said in prepared remarks. “We believe Flix will provide an innovative alternative to traditional wound closing techniques. Through its high flexibility it may enhance patient comfort after surgery.”
“Obtaining this certification is a great success for our Research & Development organization, which drives the technological and clinical development of our surgical sealant pipeline. Through the faster, more predictive and cost-conscious development, devices and technologies will improve the risk profile of our portfolio,” added CSO Klaus-Dieter Langner. “Having obtained the CE-Certification, we are now looking forward to further developing our technology platform and expanding the possible fields of application.”